Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT03851861
Eligibility Criteria:
Inclusion Criteria:
* Physician-diagnosed Parkinson's disease aged 21-85 years
* Hoehn \& Yahr stage \<3
* Currently living in the same household with a healthy spouse/partner who meets study eligibility criteria and is willing to participate
* Willing and able to complete informed consent in English
* Willing to complete daily and weekly questionnaires and 6 dietary recalls over approximately 7 weeks
* Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests.
* Willing to provide urine and stool samples during the study collection periods.
* Willing and able to fast (no food or drink, except water or tea) for a prolonged period of time during study urine collections.
* Willing to maintain usual diet through the pre-baseline period
* Willing to make dietary changes to follow a Mediterranean dietary pattern during the intervention period.
* Willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
* Willing to limit use of oral laxative medication to an "as-needed basis" (i.e. \<3 times per week) during the full length of the study
* Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on two occasions.
* Willing to provide a social security number to receive study payment.
Exclusion Criteria:
* Does not meet above criteria
* Atypical or secondary Parkinsonism
* History of deep brain stimulation
* Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
* Daily use of anticholinergics or prokinetic agents
* Use of enemas or suppositories to alleviate constipation
* Use of another investigational product within 3 months of the screening visit.
* Antibiotic use within 2 months from the day of stool collection
* Good adherence to the Mediterranean diet during the pre-baseline period (score \>6) based on the 14-item Mediterranean Diet Assessment Tool
* Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal reflux or diverticular disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT03851861
Study Brief:
Protocol Section:
NCT03851861